dm+d

10712001

Refrigerated Storage

Glucagen HypokitNovo Nordisk

Novo Nordisk
Glucagen Hypokit
Injection, 1mg

The manufacturer does not hold stability data in addition to that provided in the Summary of Product Characteristics (SPC).  Please refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

21 July 2020
London MI Service

Lactation Safety Information

Yes
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
Not absorbed from the infant's GI tract
11 September 2020

New Medicines

Baqsimi Severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.

Information

Baqsimi
New formulation
Eli Lilly
Eli Lilly

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Jan 21UK launch plans undecided [13].
Dec 19Approved in EU [12].
Oct 19Recommended for EU approval by CHMP - the full indication is "for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus." [11].
Aug 19Aug 19: Available in US [9,10].
Jul 19 Approved in US [8]
Apr 19FDA extend NDA review time by 3 months to allow for review of information requested late in the review cycle [7].
Sep 18Filed in EU [6].
Jun 18Lilly pipeline shows nasal glucagon is under regulatory review; assume filed in US [5].
May 18Lilly expects U.S. regulatory submission to occur in H1 18 [4].
Jan 18Development of commercial manufacturing process is ongoing [3].
Oct 15Lilly has bought itself worldwide rights to Locemia´s intranasal glucagon [1].

Category

Pancreatic hormone, increases plasma glucose concentration by mobilising glycogen stored in the liver [2]
According to a recent survey by Novo Nordisk, night-time hypogylcaemia is suffered by 50% of people with diabetes [1].
Severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.
Intranasal

Trial or other data

Sep 18If licensed could become the first needle-free rescue treatment for severe hypoglycaemia [1]. This will be the first dry-powder, ready-to-use spray rescue treatment for severe hypoglycemia in people with diabetes [4]. The patient has no need to inhale or breathe deeply, as the glucagon is passively absorbed through the nasal cavity – allowing anyone to administer it in an emergency [4].

Ogluo [EU]; GvokeHypoglycaemia in patients with type-1 and insulin-dependent type-2 diabetes

Information

Ogluo [EU]; Gvoke
New formulation
Xeris
Xeris

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Approved (Licensed)
Yes
Yes
May 21Licensed in UK [9].
Feb 21Approved in EU, awaiting approval by MHRA for UK [8].
Dec 20Recommended for EU approval by CHMP - the full indication is "for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus" [7].
Sep 19US launch planned in Oct/Nov 19 for the prefilled syringe and in 2020 for the autoinjector [5].
Sep 19Approved in the US to be administered via a prefilled syringe (Gvoke PFS) or auto-injector (Gvoke HypoPen) [4]

Apr 19: Still PIII in EU [3].


Dec 18: Xeris has received orphan drug status from the EMA for non-insulinoma pancreatogenous hypoglycaemia syndrome (NIPHS) and from the US FDA for treatment of hyperinsulinemic hypoglycaemia (HH). It also has orphan drug status from the FDA and the EMA for prevention of persistent and severe hypoglycaemia in patients with congenital hyperinsulinism [2].


Nov 18: FDA accepts the new drug application (NDA) for ready-to-use glucagon rescue pen for the treatment of severe hypoglycaemia, in patients with diabetes that was filed in Aug 18. June 10, 2019 was assigned as the PDUFA date [2].

Category

A room temperature-stable, non-aqueous formulation of glucagon, a polypeptide hormone released by the pancreas that stimulates the liver to convert stored glycogen into glucose and release it into the blood stream
The annual prevalence of severe hypoglycaemia is around 30% in people with type 1 diabetes. It is higher in those with risk factors - eg, strict glycaemic control, impaired awareness of hypoglycaemia and increasing duration of diabetes. It is also common during sleep - nocturnal hypoglycaemia [1].
Hypoglycaemia in patients with type-1 and insulin-dependent type-2 diabetes
Subcutaneous injection

Trial or other data

Nov 18: Efficacy results released from a PIIIb trial that evaluated the efficacy and safety of ready-to-use, liquid-stable glucagon rescue pen for the treatment of severe hypoglycaemia, in 81 patients with diabetes in the US & Canada (NCT03439072). Evaluation of the glucose response was the primary endpoint of the trial [2].


Sep 18: PIII study to evaluate the safety and efficacy of G-Pen for the treatment of hypoglycaemia in patients with type I diabetes mellitus starts (XSGP-304; NCT03738865). 122 patients will be enrolled in the US, Austria, Germany and Canada [2].


Jun 18: Xeris reports positive data from two trials. One is a PIII trial to investigate the safety and efficacy of G-Pen vs. Eli Lilly ´s glucagon for injection [rDNA origin] for hypoglycaemia rescue of patients with type 1 diabetes (NCT02656069; XSGP-301) that enrolled 80 patients in the US and Canada. The other is a PIII sequential trial that evaluated the glucose response of G-Pen for the treatment of hypoglycaemia in 31 paediatric patients with type 1 diabetes in the US (XSGP-302; NCT03091673) [2].